BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0

BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0 is an FDA 510(k)-cleared medical device (K061255) manufactured by Kyron Clinical Imaging, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 12, 2006. Regulation: 8.